Back to resultsTrial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation (COVERAGEFrance)
Primary Purpose
Corona Virus Infection, Sars-CoV2
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Vitamins
Telmisartan
Ciclesonide
interferon β-1b
Sponsored by
About this trial
This is an interventional treatment trial for Corona Virus Infection focused on measuring Corona virus, Sars-CoV2, telmisartan, ciclesonide, interferon β-1b
Eligibility Criteria
Inclusion Criteria:
- Clinical picture suggestive of COVID-19 dated 7 days or less.
- Positivity of a test proving an acute SARS-CoV-2 infection, according to current recommendations.
- Absence of criteria for hospitalization or oxygen therapy according to current recommendations.
Age :
- greater than or equal to 60 years of age without any risk factor
or between 50 and 59 years of age and the presence of at least one of the following risk factors :
- Arterial hypertension under treatment (all stages)
- Obesity (BMI ≥30 kg/m2)
- Diabetes under treatment (all types)
- Ischemic heart disease (all stages)
- Heart failure (all stages)
- Stroke History
- Chronic Obstructive Pulmonary Disease (all stages)
- Stage 3 chronic renal failure (30 ≤ Estimated GFR < 60 mL/min/1.73 m²)
- Malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed less than 5 years ago.
- Immunodeficiency
- of therapeutic origin (solid organ transplant or hematopoietic stem cell transplant, cancer chemotherapy, immunosuppressive therapy, corticosteroids > 15 mg/d of prednisone equivalent taken for at least 2 months);
- HIV infection with CD4<200/mm3.
- Valid, ambulatory person, fully able to understand the issues of the trial
- Beneficiary of a Social Security scheme
- Signed informed consent
Exclusion Criteria:
- Asymptomatic person
- Inability to make a decision to participate (dementia, person under legal protection, curatorship or guardianship)
- Ongoing illness or chronic treatment contraindicated by taking one of the trial drugs.
Sites / Locations
- Bordeaux university Hospital
- CHU de Dijon-Bourgogne
- CHU de Montpellier
- CHRU de Nancy
- Groupe hospitalier Paris Saint Joseph
- CNGE
- CHU de Toulouse
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Sham Comparator
Experimental
Experimental
Experimental
Arm Label
Vitamins
Telmisartan
Ciclesonide
interferon β-1b
Arm Description
Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days
Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days
Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days
Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days
Outcomes
Primary Outcome Measures
Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event
Efficacy phase: Death
Proportion of participants with an occurrence of death
Efficacy phase: oxygen therapy
Proportion of participants who had an indication for oxygen therapy
Efficacy phase: hospitalization
Proportion of participants who had an indication for hospitalization
Secondary Outcome Measures
Proportion of hospitalizations, overall and by cause, in each group
Death and causes of death
Proportion of deaths, overall and by cause, in each group
Proportion of intensive care hospitalizations, overall and by cause, in each group
Proportion of participants with negative SARS-CoV-2 RT-PCR
Haematological markers evolution
Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR
Inflammatory markers evolution
Evolution of Inflammatory markers in each group : PCT, CRP
Adverse events
Number and proportion of grade 1,2,3,4 adverse events in each group
Adverse reactions
Number and proportion of grade 1,2,3,4 adverse events in each group
Acceptability of the treatment
Acceptability of the treatment by participant will be assessed with an interview
Antibiotic consumption
Proportion of participants who received at least one day of antibiotic therapy
Oxygen saturation worsening
Proportion of participants who experienced a worsening of oxygen saturation
protocol follow-up
Proportion of participants who completed the prescribed protocol treatment
Full Information
NCT ID
NCT04356495
First Posted
April 11, 2020
Last Updated
February 3, 2022
Sponsor
University Hospital, Bordeaux
Collaborators
University of Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04356495
Brief Title
Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation
Acronym
COVERAGEFrance
Official Title
Randomized Trial to Evaluate the Safety and Efficacy of Outpatient Treatments to Reduce the Risk of Worsening in Individuals With COVID-19 With Risk Factors (COVERAGE France)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
October 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
University of Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.
Detailed Description
COVERAGE France is Multicenter, randomized, controlled clinical trial with for each drug :
A safety study pilot phase.
An efficacy study phase. The data collected during the pilot phase, combined with new external data that emerged during the period, will be used to position treatments for the efficacy phase.
Pilot phase will evaluate the tolerance of experimental treatments for drugs given for the first time ("first in home-based care") in ambulatory individuals with COVID-19 with aggravating risk factors.
Efficacy Phase: To estimate the effectiveness of experimental ambulatory treatments, compared to vitamin supplementation, in reducing the risk of hospitalization, oxygen therapy indication or death in ambulatory individuals with COVID-19 with aggravating risk factors.
The trial is a national platform with the vocation to open as many centers as possible, subject to criteria set by the Scientific Advisory Board.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection, Sars-CoV2
Keywords
Corona virus, Sars-CoV2, telmisartan, ciclesonide, interferon β-1b
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, randomized, controlled clinical trial with for each drug :
A safety study pilot phase.
An efficacy study phase. The data collected during the pilot phase, combined with new external data that emerged during the period, will be used to position treatments for the efficacy phase.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
412 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamins
Arm Type
Sham Comparator
Arm Description
Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days
Arm Title
Telmisartan
Arm Type
Experimental
Arm Description
Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days
Arm Title
Ciclesonide
Arm Type
Experimental
Arm Description
Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days
Arm Title
interferon β-1b
Arm Type
Experimental
Arm Description
Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamins
Intervention Description
2 tablets daily from the first day (day 0) to day 9
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Intervention Description
1 tablet daily from the first day (day 0) to day 9
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Intervention Description
2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9
Intervention Type
Drug
Intervention Name(s)
interferon β-1b
Intervention Description
A 10-minute nebulization, once a day, from the first day (day 0) to day 4, of 9.6 MIU / 300 µg of IFN-β-1b (EXTAVIA®) diluted in 2 mL of water
Primary Outcome Measure Information:
Title
Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event
Time Frame
From inclusion (day0) to day 14
Title
Efficacy phase: Death
Description
Proportion of participants with an occurrence of death
Time Frame
From inclusion (day0) to day 14
Title
Efficacy phase: oxygen therapy
Description
Proportion of participants who had an indication for oxygen therapy
Time Frame
From inclusion (day0) to day 14
Title
Efficacy phase: hospitalization
Description
Proportion of participants who had an indication for hospitalization
Time Frame
From inclusion (day0) to day 14
Secondary Outcome Measure Information:
Title
Proportion of hospitalizations, overall and by cause, in each group
Time Frame
From inclusion (day0) to day 28
Title
Death and causes of death
Description
Proportion of deaths, overall and by cause, in each group
Time Frame
From inclusion (day0) to day 28
Title
Proportion of intensive care hospitalizations, overall and by cause, in each group
Time Frame
From inclusion (day0) to day 28
Title
Proportion of participants with negative SARS-CoV-2 RT-PCR
Time Frame
day 7
Title
Haematological markers evolution
Description
Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR
Time Frame
from inclusion (day 0) to day 7
Title
Inflammatory markers evolution
Description
Evolution of Inflammatory markers in each group : PCT, CRP
Time Frame
from inclusion (day 0) to day 7
Title
Adverse events
Description
Number and proportion of grade 1,2,3,4 adverse events in each group
Time Frame
from inclusion (day 0) to day 28
Title
Adverse reactions
Description
Number and proportion of grade 1,2,3,4 adverse events in each group
Time Frame
from inclusion (day 0) to day 28
Title
Acceptability of the treatment
Description
Acceptability of the treatment by participant will be assessed with an interview
Time Frame
from inclusion (day 0) to day 10
Title
Antibiotic consumption
Description
Proportion of participants who received at least one day of antibiotic therapy
Time Frame
from inclusion (day 0) to day 28
Title
Oxygen saturation worsening
Description
Proportion of participants who experienced a worsening of oxygen saturation
Time Frame
from inclusion (day 0) to day 28
Title
protocol follow-up
Description
Proportion of participants who completed the prescribed protocol treatment
Time Frame
from inclusion (day 0) to day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical picture suggestive of COVID-19 dated 7 days or less.
Positivity of a test proving an acute SARS-CoV-2 infection, according to current recommendations.
Absence of criteria for hospitalization or oxygen therapy according to current recommendations.
Age :
greater than or equal to 60 years of age without any risk factor
or between 50 and 59 years of age and the presence of at least one of the following risk factors :
Arterial hypertension under treatment (all stages)
Obesity (BMI ≥30 kg/m2)
Diabetes under treatment (all types)
Ischemic heart disease (all stages)
Heart failure (all stages)
Stroke History
Chronic Obstructive Pulmonary Disease (all stages)
Stage 3 chronic renal failure (30 ≤ Estimated GFR < 60 mL/min/1.73 m²)
Malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed less than 5 years ago.
Immunodeficiency
of therapeutic origin (solid organ transplant or hematopoietic stem cell transplant, cancer chemotherapy, immunosuppressive therapy, corticosteroids > 15 mg/d of prednisone equivalent taken for at least 2 months);
HIV infection with CD4<200/mm3.
Valid, ambulatory person, fully able to understand the issues of the trial
Beneficiary of a Social Security scheme
Signed informed consent
Exclusion Criteria:
Asymptomatic person
Inability to make a decision to participate (dementia, person under legal protection, curatorship or guardianship)
Ongoing illness or chronic treatment contraindicated by taking one of the trial drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis MALVY, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xavier ANGLARET, Dr
Organizational Affiliation
Inserm 1219
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laura RICHERT, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
Bordeaux university Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU de Dijon-Bourgogne
City
Dijon
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHRU de Nancy
City
Nancy
Country
France
Facility Name
Groupe hospitalier Paris Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CNGE
City
Paris
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived
PubMed Identifier
33050924
Citation
Duvignaud A, Lhomme E, Pistone T, Onaisi R, Sitta R, Journot V, Nguyen D, Peiffer-Smadja N, Cremer A, Bouchet S, Darnaud T, Poitrenaud D, Piroth L, Binquet C, Michel JF, Lefevre B, Lebeaux D, Lebel J, Dupouy J, Roussillon C, Gimbert A, Wittkop L, Thiebaut R, Orne-Gliemann J, Joseph JP, Richert L, Anglaret X, Malvy D; COVERAGE study group. Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial). Trials. 2020 Oct 13;21(1):846. doi: 10.1186/s13063-020-04619-1.
Results Reference
derived
Learn more about this trial
Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation
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